Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Leon Berard
About this trial
The proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female patient > 18 years
metastatic or advanced PDAC
Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy).
Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.
Disqualifiers
Curative therapy available
Any condition contraindicated with blood sampling procedures required by the protocol.
Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
Trial design
Design model
Single group
Treatments tested in this trial
Tumor samples (archival FFPE and optional de novo biopsy) and blood samples
Biological/VaccineMolecular screening
Treatment groups
750 Participants
are divided into 1 treatment groupGroup A: Metastatic/advanced PDAC PatientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial.
Time frame
At the end of study (5 years)Secondary outcomes
1
Time from ICF signature to day 1 of next line of therapy
Time frame
At day 12
Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated
Time frame
At the end of study (5 years)3
Progression-Free Survival (PFS)
Time frame
Up to 12 months4
Best overall response (BoR)
Time frame
Up to 12 monthsOther outcomes
1
Genomic data from Next generation sequencing with gene mutations
copy number variations (CNV), Tumor mutational burden (TMB), Microsatellite instability status (MSI), and Homologous recombination status (HR: HRD or HRP)
Time frame
At the end of study (5 years)2
Transcriptomic data from RNASeq allowing to look at gene expression, fusion transcripts
to classify tumors in previously described molecular classification and to annotate tumors based on specific biological features (Epithelial-to-Mesenchymal status, CD10 signature, HOT score, …)
Time frame
At the end of study (5 years)3
Enumeration of CTCs
to follow clinical response to the treatment.
Time frame
At the end of study ( 5 years)4
Profile of surface antigens of CTCs obtained by flow cytometry
to confirm cell identity and follow the expression of new receptors predictive of treatment resistance (Her2, Met …)
Time frame
At the end of study (5 years)Sponsors and contacts
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Source ClinicalTrials.gov